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急性心肌梗死溶栓治疗中的选择偏倚。SAVE研究组

Selection bias in the use of thrombolytic therapy in acute myocardial infarction. The SAVE Investigators.

作者信息

Pfeffer M A, Moyé L A, Braunwald E, Basta L, Brown E J, Cuddy T E, Dagenais G R, Flaker G O, Geltman E M, Gersh B J

机构信息

Harvard Medical School, Brigham and Women's Hospital, Boston, Mass 02115.

出版信息

JAMA. 1991;266(4):528-32.

PMID:2061979
Abstract

OBJECTIVE

To determine whether clinical selection for thrombolytic therapy for acute myocardial infarction results in a skewed population for subsequent adverse cardiovascular events.

DESIGN

A comparison of the clinical features of the patients in the Survival and Ventricular Enlargement Study who either had or had not received thrombolytic therapy was conducted in both univariate and multiple logistic regression analyses.

SETTING

Hospitalized patients experiencing acute myocardial infarction from 112 broadly representative, private, academic, and government hospitals in the United States and Canada.

PATIENTS

All patients in the Survival and Ventricular Enlargement Study had had a recent myocardial infarction (less than 16 days) and had a left ventricular ejection fraction of 40% or less.

INTERVENTION

Thrombolytic therapy was administered to 733 patients and was not given to 1498.

MAIN OUTCOME MEASURES

The comparisons with respect to use of thrombolytic therapy were formulated after the completion of enrollment and indicated that the majority of patients did not receive thrombolytic therapy.

RESULTS

The 1498 (67.1%) patients who did not receive thrombolytic therapy were at higher risk (older age, lower functional capacity, greater likelihood of a history of prior myocardial infarction, angina, diabetes, and hypertension) for subsequent cardiovascular events and, as anticipated, were more likely to have concomitant gastrointestinal and neurological diseases. A multiple logistic regression analysis indicated that older age, prior myocardial infarction, impaired functional status, employment status, diabetes, and neurological diseases were predictors of use of thrombolytic therapy.

CONCLUSION

Although the Survival and Ventricular Enlargement Study population was selected for left ventricular dysfunction, the majority of patients who currently are judged clinically as unsuitable for thrombolytic therapy have a higher risk for adverse cardiovascular events.

摘要

目的

确定急性心肌梗死溶栓治疗的临床选择是否会导致后续不良心血管事件的人群分布不均衡。

设计

在生存与心室扩大研究中,对接受或未接受溶栓治疗的患者的临床特征进行了单因素和多因素逻辑回归分析比较。

地点

来自美国和加拿大112家具有广泛代表性的私立、学术和政府医院的急性心肌梗死住院患者。

患者

生存与心室扩大研究中的所有患者近期均发生过心肌梗死(少于16天),且左心室射血分数为40%或更低。

干预

733例患者接受了溶栓治疗,1498例未接受。

主要观察指标

在入组完成后对溶栓治疗的使用情况进行比较,结果表明大多数患者未接受溶栓治疗。

结果

未接受溶栓治疗的1498例患者(67.1%)发生后续心血管事件的风险更高(年龄更大、功能能力更低、既往心肌梗死、心绞痛、糖尿病和高血压病史的可能性更大),并且正如预期的那样,更有可能伴有胃肠道和神经系统疾病。多因素逻辑回归分析表明,年龄较大、既往心肌梗死、功能状态受损、就业状态、糖尿病和神经系统疾病是使用溶栓治疗的预测因素。

结论

尽管生存与心室扩大研究的人群是因左心室功能障碍而入选的,但目前临床上被判定为不适合溶栓治疗的大多数患者发生不良心血管事件的风险更高。

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